The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules implementing the bipartisan Food Safety Modernization Act that, for the first time, establish enforceable safety standards for produce farms and make importers accountable for verifying that imported food meets U.S. safety standards. The Agency also issued a rule establishing a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities. These final rules will help produce farmers and food importers take steps to prevent problems before they occur.

An estimated 48 million people (1 in 6 Americans) get sick each year from foodborne diseases, according to recent data from the U.S. Centers for Disease Control and Prevention. Approximately 128,000 are hospitalized, and 3,000 die each year. Over the past few years, high-profile outbreaks related to various foods, from spinach to peanut products, have underscored the need to make continuous improvements in food safety.

The

Foreign Supplier Verification Programs

rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards and that they are achieving the same level of food safety as domestic farms and food facilities. In 2013, USDA estimated that imported food accounted for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans. The final rule ensures that importers conduct verification activities (such as audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records) based on risks linked to the imported food and the performance of the foreign supplier.

The FDA has also finalized a rule on Accredited Third-Party Certification, which is part of FSMA’s new food import safety system. This rule establishes a program for the accreditation of third-party certification bodies (auditors) to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. To prevent potentially harmful food from reaching U.S. consumers, the FDA can require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.

“The ultimate success of FSMA depends on full funding of the President’s FY 2016 budget request,” Taylor said. “This will help us train FDA and state food safety staff on the new system, fund our state partners to work with farmers on produce safety, provide technical assistance to small farms and food businesses, and successfully implement the new import system that U.S. consumers deserve and Congress envisioned.”

The FDA has finalized five of the seven major rules that implement the core of FSMA. Today’s historic rules build on the preventive controls rules the FDA finalized in September 2015, which mandate modern preventive practices in food processing and storage facilities. These rules work together to systematically strengthen the food safety system and better protect public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.